March 21, 2011 -- The non-stimulant ADHD drug Strattera (atomextine) is approved for children aged 6 and older, but until now little was known about how this medication affects children younger than 6.

In a new eight-week study of 101 children aged 5 to 6 with ADHD, the drug was safe and reduced some ADHD symptoms in children, according to reports by their parents and teachers.

That said, just 40% of children treated with Strattera were "much" or "very much improved" on a clinical evaluation scale, compared with 22% of children who took placebo. Because the study was small, the percentage of children in the "much improved" or "very much improved" category was not statistically significant.

The new findings, which appear online in Pediatrics, are similar to what has been seen in older children who take this medication for ADHD.

About 3% to 5% of children and adults in the U.S have ADHD, which stands for attention deficit hyperactivity disorder. It's a behavioral disorder marked by impulsiveness, hyperactivity, and inattention.

Unlike many other medications used to treat ADHD, Straterra is not a stimulant. Instead, it works by boosting levels of the brain chemical norepinephrine, which helps reduce impulsive behavior and hyperactivity and increases attention span.

Some ADHD Symptoms Remain

"Overall, the medication did significantly reduce the symptoms of ADHD for children and was generally safe, but these children still had some symptoms," says study researcher Christopher Kratochvil, MD, a child and adolescent psychiatrist at University of Nebraska Medical Center in Omaha.

"It is important to have appropriate expectations about medication for treating ADHD," he says. "Medication alone is generally insufficient and should be combined with behavioral therapy and parent training."

The new study "gives us some information for how safe and effective it is in treating this population," he says. "It would be good to have longer-term treatment studies and comparator trials with stimulants."

Second Opinion

"Strattera is the first non-stimulant drug approved for ADHD, and in general, compared to stimulants, it does not have as striking of an effect nor as quick of an effect or as consistent of an effect as stimulants," says Andrew Adesman, MD. Adesman is the chief of developmental and behavioral pediatrics at the Steven and Alexandra Cohen Children's Medical Center of New York in New Hyde Park, N.Y.

According to Adesman, there may be other issues with using this medication in kids younger than 6 -- mainly pill swallowing. "Five-year-olds can't swallow pills and these pills are supposed to be taken as a whole," he says. The powder in the capsules can irritate the eyes, and splitting Strattera pills is not advisable.

That's not to say there isn't a role for Strattera in children, he says. For example, children who did not respond to stimulants and those who may be unable to take them due to medical problems or substance abuse in the home may benefit, he says. "There are times to think about non-stimulants, but for most kids with ADHD, clinicians should start with stimulants."

Jon Shaw, MD, a professor of psychiatry of the University of Miami School of Medicine, agrees. "Strattera is better for children with ADHD plus anxiety symptoms and for adolescents who have problems with substance abuse or addiction because they are not as potentially addictive as stimulants."

There are some downsides, he says. Strattera takes several weeks to work whereas stimulants kick in right way.

"You also can't take a drug holiday with Strattera because you need certain blood levels of the medication for it to be effective," he says. Some people stop taking stimulants for a weekend or several days to minimize the side effects such as appetite suppression and weight loss.

"We need to be judicious before jumping to use any medications to treat ADHD and try behavioral approaches first," Shaw says.